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Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter (ECLIPSE)

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ClinicalTrials.gov Identifier: NCT01602133
Recruitment Status : Unknown
Verified October 2012 by Prodimed SAS.
Recruitment status was:  Recruiting
First Posted : May 18, 2012
Last Update Posted : October 25, 2012
Information provided by (Responsible Party):
Prodimed SAS

Brief Summary:
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.

Condition or disease Intervention/treatment
Venous Puncture Procedure: peripheral venous puncture

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: one intervention arm Procedure: peripheral venous puncture
Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.

Primary Outcome Measures :
  1. length of use of the catheter measured in number of days [ Time Frame: seven days ]

Secondary Outcome Measures :
  1. adverse event during the period of use of the catheter [ Time Frame: seven days ]
    extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hospitalized patients with need of an intravenous therapy on peripheral line
  • Unsuccessful attempts at establishing a peripheral intravenous line by nurse
  • Age over 18 YO
  • Written informed consent obtained

Exclusion Criteria:

  • pregnant woman
  • local contra-indication for venous puncture
  • unconscious patient
  • need of intravenous therapy requiring central line

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602133

Contact: pascal meyer, MD pas.meyer@yahoo.fr

Centre Hospitalier Sud Francilien Recruiting
Corbeil-essonnes, France, 91 100
Sponsors and Collaborators
Prodimed SAS
Principal Investigator: Pascal Meyer, MD Centre Hospitalier Sud Francilien- Corbeil- France

Responsible Party: Prodimed SAS
ClinicalTrials.gov Identifier: NCT01602133     History of Changes
Other Study ID Numbers: 2011-A01570-41
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by Prodimed SAS:
venous puncture
seldinger technique
ultrasound guidance